Dossier Preparation (CTD/ACTD)

Preparing a regulatory dossier that meets the technical and structural requirements of global authorities is critical to the success of any pharmaceutical submission.

At DrugRegulatoryAffairs.in, we specialize in the meticulous preparation, review, and formatting of regulatory dossiers in both Common Technical Document (CTD) and ASEAN CTD (ACTD) formats.

Whether you’re targeting CDSCO (India), USFDA, EMA, or ASEAN markets, our dossier services are built to streamline submissions, reduce queries, and accelerate approvals.

Table of Contents

📘 What is a Regulatory Dossier?

A regulatory dossier is a comprehensive set of documents required to support the approval of a pharmaceutical product.

It includes everything from drug composition and clinical trial data to manufacturing details and labeling information.

The most widely accepted formats are:

CTD (Common Technical Document) – Used by USFDA, EMA, Japan, WHO, etc.
ACTD (ASEAN CTD) – Required for submissions to ASEAN countries like Malaysia, Indonesia, Philippines, etc.

📑 Services Offered

📂 Module-wise CTD/ACTD Compilation

We assist in preparing all five modules of the dossier:

Module 1: Regional Administrative Information (e.g., Form 44, Cover Letter)
Module 2: CTD Summaries (Quality Overall Summary, Clinical & Nonclinical Summaries)
Module 3: Quality Documents (Drug substance, formulation, manufacturing process)
Module 4: Nonclinical Study Reports (Toxicology data)
Module 5: Clinical Study Reports (Trial data, pharmacokinetics)

🛠 Document Formatting & Compliance

Document structuring and pagination as per authority guidelines
Creation of consistent TOCs (Tables of Contents)
Labeling and metadata tagging for eCTD submissions

📊 Dossier Review & Gap Analysis

Pre-submission audit of existing dossiers
Identification of missing or non-compliant elements
Technical corrections and scientific validation

🌐 Dossier Localization & Global Adaptation

Adaptation of dossiers for USFDA, EMA, WHO PQ, GCC & ASEAN regions
Country-specific modifications (including label and leaflet)

👥 Who Should Use This?

Indian pharma companies seeking domestic approval via Form 44
Exporters submitting dossiers to WHO, ASEAN, and Gulf markets
Contract manufacturers preparing client submission packages
Regulatory teams building new generic or FDC product filings

📈 Why Choose Us?

Expert team familiar with Indian, US, EU, and ASEAN dossier expectations
High-quality, ready-to-submit documentation
Experience with eCTD/NeeS submission platforms
Confidential, timely, and audit-ready service